Device Recall BD MAX GBS

Lot numbers 103271, 103272, 110071, 110072, 110391, 110401, 110521, 110522, 110561, 110562, 110181, 110611, 110941, 110942, 111111

Immunology and Microbiology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.

BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. || The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens.